You're right, the UK and European 150 days to evaluate regulatory filings seem to be almost meaningless, but Europe did ask for this, I believe they could act in a timely way.
Now timely, in there case could be 150 days, plus 60 or more after RFI's, but sometime next year is very possible.
Guess again Kund. The EMA counts work days i.e. days that the employees are at work, so weekends and holidays do not count against the 210 day time line.
It is not " if the file is not touched on a given day, that day is not counted." That suggests a file could sit in an in box and not have days counted.
Having said that, the EMA frequently does not meet its own timelines.
It is apparent the 3 clock stops 120, 180, 210 are more a guarantee that the company will not be left with an open ended evaluation. Viewing the information post by rx7171. These are self imposed by the agency to deadline agency responses, the company has the ball in it court between the stops.
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